FDA 510(k)

VASCULAR ACCESS CATHETER

K-Number: K851195 · 1985-06-07

Decision Date1985-06-07

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VASCULAR ACCESS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sil-Med Corp.. It received FDA 510(k) clearance on 1985-06-07 under 510(k) number K851195. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR ACCESS CATHETER?

VASCULAR ACCESS CATHETER is a medical device that received FDA 510(k) clearance on 1985-06-07. The listed applicant is Sil-Med Corp.. The 510(k) number is K851195.

When did VASCULAR ACCESS CATHETER receive FDA 510(k) clearance?

VASCULAR ACCESS CATHETER received FDA 510(k) clearance on 1985-06-07, under 510(k) number K851195.

Who is the listed applicant for VASCULAR ACCESS CATHETER?

The FDA 510(k) record lists Sil-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASCULAR ACCESS CATHETER?

The FDA product code for VASCULAR ACCESS CATHETER is LJS.

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Other records listing Sil-Med Corp. as applicant

K972521NAVIGATOR (STYLET) 2006 K961392ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II K961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN K961295SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR K960099PENROSE DRAIN MODELS 6001 - 6007 K955463GRIP-A-BOOTS

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Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.